ZURICH: Pharmaceutical group Shire said on Sunday it had obtained a preliminary injunction in a Hamburg court against rival Roche over its hemophilia drug emicizumab, alleging incomplete and misleading statements surrounding the treatment.
Swiss drugmaker Roche is hoping to win a slice of the $11 billion-a-year hemophilia drug market with emicizumab, also known as ACE910 and designed to compete with more traditional treatments from Novo Nordisk and Shire.
“Shire’s goal with this action is to ensure the hemophilia community receives sufficient, accurate information from Roche about the reported serious adverse events (SAEs) in the Phase 3 emicizumab trial, enabling physicians and their patients to make properly informed decisions about patient care.”
Roche said in an emailed statement it would not comment on Shire’s statement but said it stood behind emicizumab data and its clinical trial protocol.
“Our decisions and actions are always based on doing what is right for patients,” Roche said.
Last month, Roche said emicizumab cut the bleed rate by 87 percent in patients with resistance to standard therapy compared with those who received another treatment.
At the time, analysts cited adverse events in Roche’s studies including thrombotic microangiopathy — damage to blood vessels in vital organs — that accompanied repeated high doses of bypassing agents given to counter bleeds that occurred despite emicizumab treatment.
Shire said in a statement the injunction sought to “prevent further dissemination of the inaccurate and misleading characterization of the serious adverse events that occurred in the HAVEN 1 Phase 3 trial of emicizumab.”
“The injunction also seeks to correct promotion of the primary data results relative to ‘treated bleeds’ (a secondary endpoint) as compared to the primary endpoint of ‘number of bleeds over time’ established at the outset of the trial,” Shire said.
The preliminary injunction is an interim measure and Roche can appeal it, Shire also said.
(Reporting by Joshua Franklin. Editing by Jane Merriman)